This invention relates generally to occlusive medical devices and, in particular, to a clamp which takes advantage of the shape-memory effect to at least temporarily occlude body lumens such as such as blood vessels, bowel, esophagus, stomach, small intestine, colon, and bile ducts.
Shape-memory alloys (SMAs) are interesting materials which have the ability to change shape in response to changes in temperature. This ability to xe2x80x9crememberxe2x80x9d specific shapes corresponds to particular metallurgical phases. If deformed, a SMA can be heated or cooled to invoke a phase transformation which, in turn, induces a change in shape.
Most often, SMAs return to a predetermined shape when heated. When an SMA is cold, or below its transformation temperature, it may be deformed into various shapes and it will retain these shapes. However, when the material is heated above its transformation temperature it undergoes a change in crystal structure which causes it to return to its original shape. If the SMA encounters any resistance during this transformation, it can generate extremely large forces. This phenomenon provides a unique mechanism for remote actuation. For example, shape memory alloys have the ability to act as substitutes for muscle in robotic applications by shortening at a predetermined temperature or electrical current. When cooled, the shape memory metal can then be stretched back out to its initial length.
The most common shape-memory material is an alloy of nickel and titanium called Nitinol. This particular alloy has very good electrical and mechanical properties, long fatigue life, and high corrosion resistance. Above the transition temperature, or transition temperature range, the predominant metallurgical phase of Nitinol is termed austenite. Below the transition, the predominant phase is termed martensite.
The transformation temperatures of SMAs are typically discussed with reference to Ms and Mf, the martensitic start and finish temperatures, respectively, and As and Af, the austenitic start and finish temperatures, respectively. The transformation between these phases is reversible, such that when alloys are deformed into some first configuration while in the austenitic state, cooled into a martensitic state, deformed into a second configuration, and then re-heated to the austenitic state, the alloy will revert back to the first configuration by virtue of the martensite-to-austenite phase transformation.
Certain SMAs, including Nitinol alloys, also exhibit the ability to form stress-induced martensite as opposed to thermally-induced martensite. In such alloys, the reversible transformation between martensite and austenite occurs by the application and removal of stress rather than heat. These materials are characterized by a temperature Md which is greater than As and represents the maximum temperature at which stress-induced martensite can form. By deforming these alloys at a temperature between As and Md, the alloy transforms from its austenitic phase to a stress-induced martensitic phase. Upon release of the stress within this temperature range, the alloy reverts back to its austenitic phase and unstressed configuration. The property of Nitinol which allows it to be deformed in its austenitic state so to cause a transformation to stress-induced martensite that is transformed back to austenite by the release of stress is often termed xe2x80x9cpseudoelasticity.xe2x80x9d Strains of 8% or more are obtained in pseudoelastic Nitinol, thus making this material useful for a wide range of applications where a large amount of recoverable deformation is required.
Over the years, shape memory alloys have been applied to various mechanical devices, including pipe fittings (U.S. Pat. Nos. 4,035,007 and 4,198,081 to Harrison and Jervis), electrical connectors (U.S. Pat. No. 3,740,839 to Otte and Fischer), and switches (U.S. Pat. No. 4,205,293). SMAs have also been used in the medical field. For example, U.S. Pat. No. 3,620,212 to Fannon et al. proposes the use of an SMA intrauterine contraceptive device; U.S. Pat. No. 3,786,806 to Johnson et al. discloses an SMA bone plate, and U.S. Pat. No. 3,890,977 to Wilson proposes the use of an SMA element to bend a catheter or cannula. A useful background is provided in U.S. Pat. No. 4,665,906, which describes medical devices that make use of pseudoelastic Nitinol. In the devices described, austenitic nitinol is deformed to form stress-induced martensite, which is held in its deformed configuration by a restraining member. In this condition, the device is introduced into the body, where it is removed from the restraining member to return to its austenitic state and configuration.
U.S. Pat. No. 4,485,816 discloses the use of a shape memory surgical staple for use in holding the edges of a wound together while it heals. U.S. Pat. No. 5,002,563, discloses the use of shape memory sutures. U.S. Pat. No. 6,001,110 and PCT Publication No. WO 96/16603 describe the use of shape memory materials to address the problem of gastrointestinal bleeding. The ""110 patent in particular teaches the use of clips having pseudoelastic properties at body temperature which are used to cause hemostatis of blood vessels located along the gastrointestinal tract. Using pseudoelastic properties found in materials such as Nitinol, the clips are shaped into a first configuration that is useful for ligating blood vessels, deformed to a second configuration to facilitate placement to a desired location within the body, and released from its deformed configuration to allow a spontaneous reversion towards the first configuration.
U.S. Pat. No. 6,193,732 describes a surgical clip made from a metal material which allows the device to be forced into a final shape and then heat treated. Preferably, a shape memory alloy such as Nitinol is used. In that case, the intermediate shape is placed into and held in the desired final condition, and heat treated in that constrained condition at an elevated temperature. After heat treating, the clip is preferably quenched with water or other suitable fluid. According to one embodiment, the clip is manipulated to an open position and locked in place by a secondary member, such as pin. The clip may be opened, for example, by placing the clip in a fixture and forcing the clamp arms open using an angled wedge or other suitable tool. When the clip is constructed of a material having shape memory characteristics, the clamp arms may be completely or partially opened by cooling the surgical clip to a temperature below the transition temperature of the shape-memory alloy. Once opened, the pin is placed between the clamp arms, preferably at or near the apex of the included angle formed by the respective inner clamp surfaces or regions of clamp arms. The pin may be of any convenient cross-sectional shape having an outer dimension sufficient to hold the clamp members in an open condition with a desired operative distal opening.
U.S. Pat. No. 6,096,052 describes a device for occluding a body lumen and, in particular, a contraceptive or sterilization device for occluding a reproductive tract or lumen to prevent the passage of reproductive cells through the tract or lumen. The device generally comprises a tubular member and a mesh member, transversely disposed on the tubular member lumen. The mesh member is permeable to allow for tissue ingrowth, which produces a tissue impregnated mesh occluding the body lumen. The occluding device of the invention can be used in the fallopian tubes of a female patient, the vas deferens of a male patient, or other body lumen. The tubular member is formed from metals such as stainless steel, superelastic or shape memory material such as a nickel-titanium (NiTi) alloy such as Nitinol, platinum, tantalum, gold, or rigid or semirigid biocompatible plastics. In a preferred embodiment, the tubular member is a superelastic material, providing a controlled force on the body lumen during expansion of the tubular member.
Substantially spherical occlusive devices for inserting into body cavities or vesicles are disclosed in U.S. Pat. No. 6,090,125. The devices feature a self-forming shape made from a pre-formed occlusive strand of flexible material. The occlusive strand may be helically coiled or braided and may be adapted with various polymeric fibers. The device is typically introduced through a catheter in the substantially linear inoperable configuration. The invention provides a plurality of such substantially spherical strand portions which nest concentrically with each other in the operable configuration. Preferably, the strand is a wire constructed of a radiopaque material such as a metal or a polymer. Very desirable materials of construction, from a mechanical point of view, are those which maintain their shape despite being subjected to high stress. Particularly preferred are the alloys described in U.S. Pat. Nos. 3,174,851; 3,351,463; and 3,753,700. Especially preferred is the titanium/nickel alloy known as Nitinol.
Despite these applications of shape-memory alloys, certain medical appliances are still in need of improvement. One example is vascular clamps, which are utilized to occlude arteries and veins so that blood flow is stopped during procedures to repair, anastomose, or remove thrombus or foreign objects. Due to the forces needed to close the lumen of an artery, clamps usually have long handles. These handles often get in the way of doing the procedure. As such, any approach that would reduce the profile of such devices or instruments would be welcomed by the medical/surgical community.
This invention improves upon the existing art by providing a vessel-occluding clamp which takes advantage of the shape-memory effect. Although the invention is particularly suited to cardiovascular applications, the apparatus and methods may be directed to other body lumens besides blood vessels, including bowel, esophagus, stomach, small intestine, colon, and bile ducts. The self-actuating nature of the clamp allows the device work in tight places, be placed through trocars for minimal-access procedures, and forgo the need for conventional or specific applicators.
In the preferred embodiment, a clamp according to the invention a pair of opposing jaws connected through a hinge and one or more pieces of shape-memory material associated with the jaws. For example, the shape-memory material may be in the form of one or more wires which extend from the hinge to each jaw. Although each wire is anchored to a respective jaw, each wire can preferably move within or relative to the jaw to achieve the effect of a strong muscle.
The shape-memory material exhibits a transition temperature such that, when the clamp is exposed to internal body temperatures of the type experienced during a typical surgical procedure, the jaws close to close partially or completely occlude the vessel, and wherein the jaws open below the transition temperature for removal of the clamp or to restore flow through the vessel.
The transition temperature is preferably such that the jaws open in the presence of cooling irrigation. Other stimuli, such as the application of an electrical current, may alternatively be used. In an alternative embodiment, a second shape memory material is used having a second transition temperature which, when reached, causes the jaws to open.
The jaws are substantially parallel to one another and smooth where the vessel is partially or completely occluded so as not to damage the vessel when the jaws are closed. The jaws are also preferably non-locking so that they open only through a change in temperature. As an option, the jaws may include padding where they occlude the vessel, and the padding may be of the type which readily releases from the jaws.